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- EEC directive n. 93/42 – Medical Devices (D.Lgs. n° 46/1997)
- EEC directive n.73/23 – Low voltage Directive (Italian legislation: Law n°
791/1977, Decree Law n° 626/1996, Decree Law n° 277/97)
- EEC directive n.89/336 relative to Electromagnetic Compatibility (EMC)
- (Italian legislation: Decree Law n° 615/1996)
- DPR 27.4.1955 n.547, "Norme per la prevenzione degli infortuni sul
lavoro" (work accident prevention regulations)
- DPR 27.4.1956 n.303, "Norme generali per l'igiene del lavoro" (general
work hygiene regulations)
- Italian Decree Law 12 August 1991 n.277 implementing EEC directives
n.80/605; n.83/477; 86/188; 88/642 concerning the protection of
workers against risks deriving from exposure to chemical, physical and
biological agents in the workplace, as defined by art. 7 of Law 30 July
1990, n.212.
- Legislative Decree No. 151 of 25
2002/95/EC, 2002/96/EC and 2003/108/EC relative to reduction of the
use of hazardous substances in electrical and electronic equipment as
well as waste disposal.
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- CEI EN 60601-1 (1998) Electromedical appliances - Part 1 – General safety
regulations.
- CEI EN 60601-2-2 (2000) Electromedical appliances - Part 1 - Special
regulations for the safety of high frequency apparatuses for
electrosurgery.
- CEI EN 60601-1-2 (2001) Electromedical appliances - Part 1 – General safety
regulations - Supplementary standard: electromagnetic compatibility –
Prescriptions and tests.
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The user must install the appliance in a suitable place equipped with an
electrical system that complies with established legislation.
The appliance must be installed in a dry environment that is illuminated in
accordance with the requirements of established legislation.
NOTE: The expression "established legislation" refers to the laws in force in the
user's country.
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July 2005 implementing EC Directives
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